エンフロン® II ミニ・クリーンパック™ カプセルフィルター product photo Primary L

エンフロン® II ミニ・クリーンパック™ カプセルフィルター

Small Scale, Gamma Compatible, Sterilizing Grade Air Filtration

For single-use installations, from upstream to final formulation and fill, Emflon II membrane is the go-to gas filter for safeguarding cell cultures and drug product from adventitious bacterial and viral contamination.

Mini Kleenpak capsules with Emflon II membrane deliver gamma-compatible sterilizing grade air filtration for use on process gas and vent applications. With a comprehensive validation and quality package, these PVDF capsule filters are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

Features and Benefits

  • Highly-retentive Emflon II membrane for sterility assurance
  • High flow-rates associated with low differential pressure enable the use of small filters, leading to reduction of installation and operating costs
  • Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience
  • Integrity testable using the forward flow and bubble point test
  • Choice of connection options for enhanced flexibility

High Quality Standards

  • Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 organisms/cm2 of filter area
  • 100 % integrity tested during manufacturing
  • Identified by a lot number and unique serial number for complete traceability of manufacturing history and for user traceability systems
  • Comprehensive batch/release testing supported with a Pharmaceutical Certificate of Test for each filter
  • Validation guide available
  • Manufactured under a quality management system certified to ISO 9001:2015

Biological Tests

  • Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C.


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ダウンロード: 英語

概要

Small Scale, Gamma Compatible, Sterilizing Grade Air Filtration

For single-use installations, from upstream to final formulation and fill, Emflon II membrane is the go-to gas filter for safeguarding cell cultures and drug product from adventitious bacterial and viral contamination.

Mini Kleenpak capsules with Emflon II membrane deliver gamma-compatible sterilizing grade air filtration for use on process gas and vent applications. With a comprehensive validation and quality package, these PVDF capsule filters are the perfect air filter technology to implement through clinical development to licensed drug manufacture.

Features and Benefits

  • Highly-retentive Emflon II membrane for sterility assurance
  • High flow-rates associated with low differential pressure enable the use of small filters, leading to reduction of installation and operating costs
  • Gamma-irradiatable, autoclavable or available pre-sterilized for maximum convenience
  • Integrity testable using the forward flow and bubble point test
  • Choice of connection options for enhanced flexibility

High Quality Standards

  • Validated in liquids with Brevundimonas diminuta (ATCC 19146) at a challenge level of 107 organisms/cm2 of filter area
  • 100 % integrity tested during manufacturing
  • Identified by a lot number and unique serial number for complete traceability of manufacturing history and for user traceability systems
  • Comprehensive batch/release testing supported with a Pharmaceutical Certificate of Test for each filter
  • Validation guide available
  • Manufactured under a quality management system certified to ISO 9001:2015

Biological Tests

  • Meets USP biological reactivity tests in vivo, in accordance with USP class VI plastics at 121°C.

仕様

Materials of Construction

  • Membrane: Hydrophobic PVDF
  • Support and Drainage Layers: Polypropylene
  • End Cap, Core and Cage: Polypropylene
  • Outer Shell: Polypropylene

Nominal Dimensions

  • Maximum Diameter (Including Valves):

    67 mm (2.6 in.)

  • Length with Hose Barb Connections (Code 2):

    105 mm (4.1 in.)

  • Length with sanitary connections (Code 8):

    73 mm (2.9 in.)

  • Nominal filtration area:

    230 cm2 (0.25 ft2 )

Sterilization

  • Gamma-irradiation maximum dosage(G option only):

    Up to 50 kGy

  • Autoclave sterilization:

    - Gamma-irradiated filters: 1 one-hour cycle at 125 ºC for the purpose of post-use decontamination

    – Non gamma-irradiated filters: Up to 3 one-hour cycles at 125 ºC

Warning: Mini Kleenpak filters must not be in situ steam-sterilized by passing steam through under pressure. The figures are maximum allowable figures determined by testing under controlled laboratory conditions to the total number of hours indicated. Actual operating conditions may affect the filters long-term response to sterilization. Filters should be qualified for each process application

Operating Conditions1

  • Maximum operating pressure:

    4.1 bar (60 psi) at 38 °C

1 In air/nitrogen gas service or other compatible fluids,which do not soften, swell, or adversely affect the filter or its materials of construction.

Typical Air Flow Rates2, 3

Figure 1

Vent conditions for Mini Kleenpak capsules KA02

Figure 2

Operating conditions (2 bar) for Mini Kleenpak capsules

2For gases other than air or nitrogen, contact your local Pall representative

3 Recommended flow limits have been based on a maximum velocity of 25 m/s through the capsule. Customer tubing sizes should also be considered.

製品カテゴリー

カプセルフィルター

型式

 
Part Number Description
KA02V002P2S Mini Kleenpak capsule with Emflon II membrane with ¼ to ½ in. hose barb, gamma-irradiated
KA02V002P2G Mini Kleenpak capsule with Emflon II membrane with ¼ to ½ in. hose barb, non irradiated
KA02V002P8S Mini Kleenpak capsule with Emflon II membrane with ½ in. sanitary flange, gamma-irradiated
KA02V002P8G Mini Kleenpak capsule with Emflon II membrane with ½ in. sanitary flange, non irradiated
 

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